Lumbar Disc Herniation With RadiculopathyNCT07234071
Manual Therapy Combined With Functional Magnetic Stimulation for Lumbar Radiculopathy
A study testing Combined manual therapy and Functional Magnetic Stimulation and Manual Therapy without Functional Magnetic Stimulation in people with Lumbar Disc Herniation With Radiculopathy, run by International Hellenic University at 1 site in Greece.
Trial summary
This randomized clinical trial will evaluate whether adding Functional Magnetic Stimulation (FMS) to manual therapy (neurodynamic mobilization) improves clinical outcomes in adults with lumbar radiculopathy caused by lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lumbar Disc Herniation With Radiculopathy
- What is being tested?
- Combined manual therapy and Functional Magnetic Stimulation and Manual Therapy without Functional Magnetic Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 5 Nov 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Candidates will be excluded if any of the following conditions are present:
- Clinical "red flag" indicators such as cauda equina syndrome, suspected spinal infection, or oncologic disease.
- Bilateral radicular involvement or symptoms inconsistent with a single-level LDHR.
- Previous lumbar spine surgery or an upcoming surgical intervention scheduled during the study period.
- Receipt of invasive pain-management procedures (e.g., epidural steroid injections) within the last six weeks.
- Coexisting severe neurologic, metabolic, or inflammatory rheumatologic diseases unrelated to the lumbar radiculopathy.
- Contraindications to magnetic stimulation, including pacemakers, spinal or peripheral neurostimulators, cochlear implants, or clinically significant metallic implants in the stimulation field.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Manual Therapy Combined With Functional Magnetic Stimulation in Individuals With Lumbar Radiculopathy Due to Lumbar Disc Herniation: A Randomized Controlled Trial
This randomized clinical trial will evaluate whether adding Functional Magnetic Stimulation (FMS) to manual therapy (neurodynamic mobilization) improves clinical outcomes in adults with lumbar radiculopathy caused by lumbar disc herniation. Forty participants will be randomly assigned to two groups: an intervention group receiving manual therapy combined with FMS and a control group receiving manual therapy alone. All participants will complete a three-week physiotherapy program consisting of ten treatment sessions. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcomes include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) range of motion measured with goniometry, and neuropathic symptom characteristics (S-LANSS, Greek). The study aims to determine whether the addition of FMS produces superior clinical improvements compared with manual therapy alone.
Read the detailed description
Background: Lumbar disc herniation with radiculopathy is a common musculoskeletal and neurological condition caused by compression or irritation of the lumbar nerve roots, often leading to radiating leg pain, paresthesia, and movement limitation. Neural (neurodynamic) mobilization is a manual physiotherapy technique aiming to restore the mechanical and physiological interface between neural tissues and their surrounding structures, thereby improving nerve mobility and reducing mechanosensitivity. Functional Magnetic Stimulation (FMS) is a non-invasive modality that induces deep neuromuscular activation through rapidly changing magnetic fields, potentially enhancing circulation, muscle recruitment, and neural responsiveness. Although FMS has shown promise in both neurological and musculoskeletal disorders, its combined use with neural mobilization in patients with lumbar radiculopathy has not yet been evaluated in a controlled clinical environment.
Aim: This randomized controlled trial aims to investigate the effectiveness of combining manual therapy with Functional Magnetic Stimulation in adults with chronic lumbar radiculopathy due to lumbar disc herniation. The primary objective is to determine whether the combined intervention provides greater reductions in pain, improved functional capacity, and better neuropathic symptom profiles compared with manual therapy alone.
Method: Forty adults aged 18-64 years with clinically and MRI-confirmed lumbar radiculopathy will be randomly assigned to two groups. The intervention group will participate in a three-week physiotherapy program consisting of manual therapy techniques and Functional Magnetic Stimulation applied 3-4 times per week (10 sessions total). The control group will receive the same manual therapy protocol without FMS. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcome measures include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) angle measured with a goniometer, and neuropathic pain features (S-LANSS, Greek). A mixed-model repeated-measures ANOVA will be used for statistical analysis, with significance set at p < .05.
Expected Results: It is anticipated that individuals receiving the combined manual therapy and FMS intervention will demonstrate greater improvements in pain intensity, functional capacity, and neuropathic symptom characteristics compared with those receiving manual therapy alone.
- Being tested
- Combined manual therapy and Functional Magnetic Stimulation, Manual Therapy without Functional Magnetic Stimulation
- Keywords
- Lumbar Radiculopathy, Low Back Pain, Root Compression, Neuropathic Pain, Acute Radicular Pain
- Medical subject headings
- Radiculopathy, Low Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined manual therapy and Functional Magnetic StimulationOther
Participants allocated to this group will receive a combined program consisting of neurodynamic manual therapy and Functional Magnetic Stimulation (FMS). The manual therapy protocol includes symptom-guided spinal mobilization with leg movement and standardized sciatic nerve mobilization techniques. FMS will be applied using a high-intensity magnetic stimulator targeting the lumbosacral nerve roots and the sciatic nerve pathway. A total of 10 treatment sessions will be administered over a 3-week period.
Manual Therapy without Functional Magnetic StimulationOther
Participants in this group will receive the same neurodynamic manual therapy protocol as the experimental group, including symptom-guided spinal mobilization with leg movement and sciatic nerve mobilization techniques. However, they will not receive Functional Magnetic Stimulation (FMS). A total of 10 treatment sessions will be administered over the 3-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy and Functional Magnetic Stimulation | Experimental | Participants allocated to this group will receive 10 sessions of manual therapy with Functional Magnetic Stimulation Receives: Other: Combined manual therapy and Functional Magnetic Stimulation |
| Manual Therapy without Functional Magnetic Stimulation | Active comparator | Participants allocated to this group will receive 10 sessions of a Manual Therapy without Functional Magnetic Stimulation. Receives: Other: Manual Therapy without Functional Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity with Numeric Rating Scale (NPRS)
Changes in pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10. A score of 0 represents "no pain", while 10 represents "the worst possible pain". Two separate pain ratings will be recorded: lumbar pain (NPRS-Lumbar pain) and radicular leg pain (NPRS-Leg pain). Participants will be asked to select the number that best reflects their average pain intensity. The NPRS is a widely accepted tool for evaluating pain in both clinical and research settings, demonstrating excellent test-retest reliability and strong construct validity (Childs et al., 2005).
Measured: pre-treatment, week 3
Straight Leg Raise (SLR) Angle - Goniometry/SROM
Neural mechanosensitivity will be assessed with the passive Straight Leg Raise (SLR) measured using a universal goniometer (SROM). With the participant supine, the hip is passively flexed with the knee extended while the pelvis is stabilized. The assessor records: the Symptom Onset Angle (SOA)-the hip flexion angle (°) at which the participant's typical radicular symptoms first appear. Standardized sensitization maneuvers (e.g., ankle dorsiflexion) may be applied consistently to confirm neural involvement. Higher angles indicate reduced neural mechanosensitivity. The SLR SROM shows good repeatability when the procedure and landmarks are standardized.
Measured: pre-treatment, week 3
Change in Functional Disability
Functional disability will be evaluated using the Roland-Morris Disability Questionnaire (RMDQ), a self-administered instrument specifically designed to measure the impact of low back pain on daily functioning. The questionnaire consists of 24 statements related to physical activities and functional limitations commonly affected by back pain. Participants are asked to mark each statement that applies to them on the day of assessment. The total score ranges from 0 to 24, with higher scores indicating greater disability and reduced functional capacity. The RMDQ is a validated, reliable, and sensitive tool frequently used in both clinical and research contexts to monitor changes in function over time in individuals with low back pain.
Measured: pre-treatment, week 3
Change in Neuropathic Symptom Profile - S-LANSS
Neuropathic pain features will be evaluated with the Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item questionnaire producing a total score from 0 to 24. Items capture characteristic symptoms (e.g., burning, electric shocks, paresthesias) and symptom behavior. Scores ≥12 suggest pain predominantly of neuropathic origin. The S-LANSS is brief, easy to administer, and has demonstrated acceptable reliability and validity for screening neuropathic pain components and monitoring change over time.
Measured: pre-treatment, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start5 Nov 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation With RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-assessor-blind randomized controlled trial will be conducted over three weeks in forty adults with lumbar radiculopathy due to lumbar disc herniation. Participants will be randomly allocated 1:1 (n = 20 per group) to either: (1) manual therapy (neurodynamic mobilization) combined with Functional Magnetic Stimulation (FMS), or (2) the same manual therapy protocol without FMS. Both groups will complete ten treatment sessions during the three-week period. Clinical assessments-including pain intensity (Numeric Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), straight leg raise (SLR) angle measured with goniometry, and neuropathic symptoms (S-LANSS, Greek)-will be obtained at baseline and at the end of the three-week intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234071
- Sponsor's protocol ID
- EC-16/2025
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Therapy Combined With Functional Magnetic Stimulation in Individuals With Lumbar Radiculopathy Due to Lumbar Disc Herniation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07234071
- Acronym / sponsor ID
- EC-16/2025
- Keywords
- Lumbar Radiculopathy, Low Back Pain, Root Compression, Neuropathic Pain, Acute Radicular Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will evaluate whether adding Functional Magnetic Stimulation (FMS) to manual therapy (neurodynamic mobilization) improves clinical outcomes in adults with lumbar radiculopathy caused by lumbar disc herniation. Forty participants will be randomly assigned to two groups: an intervention group receiving manual therapy combined with FMS and a control group receiving manual therapy alone. All participants will complete a three-week physiotherapy program consisting of ten treatment sessions. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcomes include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) range of motion measured with goniometry, and neuropathic symptom characteristics (S-LANSS, Greek). The study aims to determine whether the addition of FMS produces superior clinical improvements compared with manual therapy alone.
Detailed description
Background: Lumbar disc herniation with radiculopathy is a common musculoskeletal and neurological condition caused by compression or irritation of the lumbar nerve roots, often leading to radiating leg pain, paresthesia, and movement limitation. Neural (neurodynamic) mobilization is a manual physiotherapy technique aiming to restore the mechanical and physiological interface between neural tissues and their surrounding structures, thereby improving nerve mobility and reducing mechanosensitivity. Functional Magnetic Stimulation (FMS) is a non-invasive modality that induces deep neuromuscular activation through rapidly changing magnetic fields, potentially enhancing circulation, muscle recruitment, and neural responsiveness. Although FMS has shown promise in both neurological and musculoskeletal disorders, its combined use with neural mobilization in patients with lumbar radiculopathy has not yet been evaluated in a controlled clinical environment.
Aim: This randomized controlled trial aims to investigate the effectiveness of combining manual therapy with Functional Magnetic Stimulation in adults with chronic lumbar radiculopathy due to lumbar disc herniation. The primary objective is to determine whether the combined intervention provides greater reductions in pain, improved functional capacity, and better neuropathic symptom profiles compared with manual therapy alone.
Method: Forty adults aged 18-64 years with clinically and MRI-confirmed lumbar radiculopathy will be randomly assigned to two groups. The intervention group will participate in a three-week physiotherapy program consisting of manual therapy techniques and Functional Magnetic Stimulation applied 3-4 times per week (10 sessions total). The control group will receive the same manual therapy protocol without FMS. Outcomes will be assessed at baseline and at the end of the three-week intervention period. Primary outcome measures include pain intensity (Numeric Pain Rating Scale, NPRS), functional disability (Roland-Morris Disability Questionnaire, RMDQ), straight leg raise (SLR) angle measured with a goniometer, and neuropathic pain features (S-LANSS, Greek). A mixed-model repeated-measures ANOVA will be used for statistical analysis, with significance set at p < .05.
Expected Results: It is anticipated that individuals receiving the combined manual therapy and FMS intervention will demonstrate greater improvements in pain intensity, functional capacity, and neuropathic symptom characteristics compared with those receiving manual therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-assessor-blind randomized controlled trial will be conducted over three weeks in forty adults with lumbar radiculopathy due to lumbar disc herniation. Participants will be randomly allocated 1:1 (n = 20 per group) to either: (1) manual therapy (neurodynamic mobilization) combined with Functional Magnetic Stimulation (FMS), or (2) the same manual therapy protocol without FMS. Both groups will complete ten treatment sessions during the three-week period. Clinical assessments-including pain intensity (Numeric Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), straight leg raise (SLR) angle measured with goniometry, and neuropathic symptoms (S-LANSS, Greek)-will be obtained at baseline and at the end of the three-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy and Functional Magnetic Stimulation | Experimental | Other: Combined manual therapy and Functional Magnetic StimulationParticipants allocated to this group will receive 10 sessions of manual therapy with Functional Magnetic Stimulation |
| Manual Therapy without Functional Magnetic Stimulation | Active comparator | Other: Manual Therapy without Functional Magnetic StimulationParticipants allocated to this group will receive 10 sessions of a Manual Therapy without Functional Magnetic Stimulation. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Candidates will be excluded if any of the following conditions are present:
- Clinical "red flag" indicators such as cauda equina syndrome, suspected spinal infection, or oncologic disease.
- Bilateral radicular involvement or symptoms inconsistent with a single-level LDHR.
- Previous lumbar spine surgery or an upcoming surgical intervention scheduled during the study period.
- Receipt of invasive pain-management procedures (e.g., epidural steroid injections) within the last six weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined manual therapy and Functional Magnetic StimulationParticipants allocated to this group will receive a combined program consisting of neurodynamic manual therapy and Functional Magnetic Stimulation (FMS). The manual therapy protocol includes symptom-guided spinal mobilization with leg movement and standardized sciatic nerve mobilization techniques. FMS will be applied using a high-intensity magnetic stimulator targeting the lumbosacral nerve roots and the sciatic nerve pathway. A total of 10 treatment sessions will be administered over a 3-week period. | Other | Manual Therapy and Functional Magnetic Stimulation |
| Manual Therapy without Functional Magnetic StimulationParticipants in this group will receive the same neurodynamic manual therapy protocol as the experimental group, including symptom-guided spinal mobilization with leg movement and sciatic nerve mobilization techniques. However, they will not receive Functional Magnetic Stimulation (FMS). A total of 10 treatment sessions will be administered over the 3-week intervention period. | Other | Manual Therapy without Functional Magnetic Stimulation |
Primary outcome
Changes in pain intensity with Numeric Rating Scale (NPRS)
Time frame: pre-treatment, week 3
Changes in pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10. A score of 0 represents "no pain", while 10 represents "the worst possible pain". Two separate pain ratings will be recorded: lumbar pain (NPRS-Lumbar pain) and radicular leg pain (NPRS-Leg pain). Participants will be asked to select the number that best reflects their average pain intensity. The NPRS is a widely accepted tool for evaluating pain in both clinical and research settings, demonstrating excellent test-retest reliability and strong construct validity (Childs et al., 2005).
Straight Leg Raise (SLR) Angle - Goniometry/SROM
Time frame: pre-treatment, week 3
Neural mechanosensitivity will be assessed with the passive Straight Leg Raise (SLR) measured using a universal goniometer (SROM). With the participant supine, the hip is passively flexed with the knee extended while the pelvis is stabilized. The assessor records: the Symptom Onset Angle (SOA)-the hip flexion angle (°) at which the participant's typical radicular symptoms first appear. Standardized sensitization maneuvers (e.g., ankle dorsiflexion) may be applied consistently to confirm neural involvement. Higher angles indicate reduced neural mechanosensitivity. The SLR SROM shows good repeatability when the procedure and landmarks are standardized.
Change in Functional Disability
Time frame: pre-treatment, week 3
Functional disability will be evaluated using the Roland-Morris Disability Questionnaire (RMDQ), a self-administered instrument specifically designed to measure the impact of low back pain on daily functioning. The questionnaire consists of 24 statements related to physical activities and functional limitations commonly affected by back pain. Participants are asked to mark each statement that applies to them on the day of assessment. The total score ranges from 0 to 24, with higher scores indicating greater disability and reduced functional capacity. The RMDQ is a validated, reliable, and sensitive tool frequently used in both clinical and research contexts to monitor changes in function over time in individuals with low back pain.
Change in Neuropathic Symptom Profile - S-LANSS
Time frame: pre-treatment, week 3
Neuropathic pain features will be evaluated with the Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item questionnaire producing a total score from 0 to 24. Items capture characteristic symptoms (e.g., burning, electric shocks, paresthesias) and symptom behavior. Scores ≥12 suggest pain predominantly of neuropathic origin. The S-LANSS is brief, easy to administer, and has demonstrated acceptable reliability and validity for screening neuropathic pain components and monitoring change over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined manual therapy and Functional Magnetic Stimulation and Manual Therapy without Functional Magnetic Stimulation in people with Lumbar Disc Herniation With Radiculopathy, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity with Numeric Rating Scale (NPRS) (time frame: pre-treatment, week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.